RecruitingNot Applicable

Effectiveness of the Fascial Distortion Model in Temporomandibular Disorders: A Randomized Sham-controlled Trial

Turkey (Türkiye)30 participantsStarted 2024-10-03

Plain-language summary

The aim of the study was to investigate the effectiveness of Manual Therapy Based on the Fascial Distortion Model in individuals with temporomandibular disorders compared to sham control. Individuals diagnosed with temporomandibular disorder will be randomly assigned to groups as Group 1 (Manual Therapy Based on Fascial Distortion Model) and Group 2 (Sham Control). Head posture, cervical and temporomandibular joint range of motion, cervical muscle performance, pain intensity, pressure pain thresholds, temporomandibular disorder severity, disability, dysfunction, health-related quality of life, kinesiophobia, and central sensitization will be assessed.

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Having temporomandibular joint complaints and being diagnosed with temporomandibular disorder according to the Diagnostic Criteria for Temporomandibular Disorders Axis I * Understand and be willing to answer assessment questions * A temporomandibular joint complaint for the last three months * Pain in the jaw, face or neck Exclusion Criteria: * Has a systemic disease (neurological, rheumatologic, oncologic, etc.) that may affect the temporomandibular joint, cervical spine and/or assessment * Any history of trauma that may have affected the cranio-cervico-facial region * Having undergone any surgical intervention in the cranio-cervico-facial region within the last six months * Receiving surgical treatment, medical treatment, splint therapy or physiotherapy for temporomandibular disorder in the last month * Radiotherapy in the head and neck region * Pregnancy or breastfeeding * Exercise therapy for craniocervical posture for the last month

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Head posture

Timeframe: From enrollment to the end of treatment at 4th week

Cervical range of motions

Timeframe: From enrollment to the end of treatment at 4th week

Temporomandibular range of motions

Timeframe: From enrollment to the end of treatment at 4th week

Cervical muscle performance

Timeframe: From enrollment to the end of treatment at 4th week

Pressure pain threshold

Timeframe: From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.

Pain intensity in the last week

Timeframe: From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.

Chronic pain intensity

Timeframe: From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.

Trial details

NCT IDNCT06627855

SponsorKarabuk University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-15

Contact for this trial

Harun Gençosmanoğlu, PT, MSc

+903704189093 harungencosmanoglu@karabuk.edu.tr

View on ClinicalTrials.gov More Temporomandibular Disorders (TMD) trials

Plain-language summary

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Head posture

Timeframe: From enrollment to the end of treatment at 4th week

Cervical range of motions

Timeframe: From enrollment to the end of treatment at 4th week

Temporomandibular range of motions

Timeframe: From enrollment to the end of treatment at 4th week

Cervical muscle performance

Timeframe: From enrollment to the end of treatment at 4th week

Pressure pain threshold

Timeframe: From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.

Pain intensity in the last week

Timeframe: From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.

Chronic pain intensity

Timeframe: From enrollment to the end of treatment at 1st week, 2nd week, 3rd week, and 4th week.